Clinical Performance of MTA Cavity Lining in the Treatment of Deep Caries Lesions

Clinical Performance of MTA Cavity Lining in the Treatment of Deep Caries Lesions: A 4- Year Randomized Controlled Clinical Trial

Aim of this clinical study is to compare the clinical success of two lining materials regarding the maintenance of pulp vitality in the treatment of deep caries lesions over 4- years.

A hundred permanent premolar and molars with deep caries lesions without pulp involvement (aged between 18 and 30 years) in 73 patients were randomly divided into the following groups: calcium hydroxide cement (Ca(OH)2) (Dycal, Dentsply/Caulk, Dentsply International Inc, Milford, DE, USA) group and mineral trioxide aggregate (MTA) (Dentsplay, Tulsa Dental, Johnson city, USA) group. Final restoration with a resin-based composite (Gradia Direct Posterior, GC, Tokyo, Japan) in a single session was performed. The following-up period was 6-, 12-, 24-, 36- and 48-months. Two calibrated examiners performed the clinical examination of the pulpal symptoms

Study Overview

• Status: Unknown
• Conditions: Indirect Pulp Capping; Mineral Trioxide Aggregate; Calcium Hydroxide
• Intervention / Treatment: Device: MTA; Device: Dycal

Detailed Description

Aim of this clinical study is to compare the clinical outcomes of mineral trioxide aggregate (MTA) cavity lining with calcium hydroxide (Ca(OH)2) regarding the maintenance of pulp vitality in the treatment of deep caries lesions over 4- years.

Materials and Methods: A hundred permanent premolar and molars with deep caries lesions without pulp involvement (aged between 18 and 30 years) in 73 patients were randomly divided into the following groups: calcium hydroxide cement (Ca(OH)2) (Dycal, Dentsply/Caulk, Dentsply International Inc, Milford, DE, USA) group and mineral trioxide aggregate (MTA) (Dentsplay, Tulsa Dental, Johnson city, USA) group. Final restoration with a resin-based composite (Gradia Direct Posterior, GC, Tokyo, Japan) in a single session was performed. The following-up period was 6-, 12-, 24-, 36- and 48-months. Two calibrated examiners performed the clinical examination of the pulpal symptoms. The data will be analyzed with Pearson chi-square, Fisher exact and logrank statistics tests (p < 0.05). The Kaplan-Meier survival analysis will be conducted to reveal the survival rate.

• Study Type: Interventional
• Enrollment (Anticipated): 73
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 28 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Primary deep caries lesion with risk of pulp exposure (radiograph depth reaching 3/4 of the dentin).
2. Restorable by direct restoration and functional permanent posterior teeth,
3. Positive response to electric pulp testing and negative response to thermal testing.

Exclusion Criteria:

1. Two or more cuspal loss 2. Caries beneath the gingival margin 3. Spontaneous pain history 4. Presence of any periapical pathology 5. Immature teeth with open apex 6. Pathologic mobility

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MTA; mineral trioxide aggregate	Device: MTA; Indirect capping with MTA
Active Comparator: Dycal; calcium hydroxide cement	Device: Dycal; Indirect capping with Dycal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluating of clinical success of restorations	The treatment consequence was judged as "clinically successful" when the following criteria were met: positive response to electric pulp testing, negative response to cold stimuli by air-water shrinkage, no general pain, normal response to tactile tests or triggered pain not lingering, no evidence of abscess, sinus tract and no abnormal tooth mobility. These teeth were considered to be "clinically healthy" and the treatment was successful.	6 months

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2015
• Primary Completion (Actual): January 7, 2016
• Study Completion (Anticipated): July 7, 2019

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 12, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: calcium hydroxide; randomized clinical trial; mineral trioxide aggregate; deep dentin caries; total caries excavation
• Other Study ID Numbers: HEK 11/106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No